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Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone

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ClinicalTrials.gov Identifier: NCT02091297
Recruitment Status : Withdrawn (two other institutions that were in the center thought they weren't going to be able to recruit enough patients)
First Posted : March 19, 2014
Last Update Posted : August 5, 2016
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE March 19, 2014
Last Update Posted Date August 5, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
  • Acute pain by narcotic use after cesarean section [ Time Frame: 0-48 hours after surgery ]
    Directly compare narcotic use in patients who have a TAP block, who have a patient - controlled epidural analgesia, or common care ( neuraxial opioid alone) while in the hospital / acute pain after Cesarean Section Will use morphine equivalents
  • Acute pain by pain scores after cesarean section [ Time Frame: 0-48 hours ]
    Directly compare pain scores in patients who have a TAP block, who have a patient - controlled epidural analgesia, or common care ( neuraxial opioid alone) while in the hospital / acute pain after Cesarean Section Will use VAS (0-10), pain at rest, pain with movement
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2014)
  • Chronic pain by narcotic use [ Time Frame: 6 weeks post-partum ]
    Directly compare narcotic use in the three groups at the six week visit, evaluating for chronic pain after Cesarean Section. Will use dose of buprenorphine and/or methadone Will use morphine equivalents
  • Respiratory depression [ Time Frame: 0-48 hours ]
    Oxygen requirement, narcan use (yes / no), rapid response or code blue called
  • Perception of Quality in Anesthesia / Maternal Satisfaction [ Time Frame: 0-48 hours ]
    Using the validated, "Perception of Quality in Anaesthesia (PQA) questionnaire", the patients assessed their overall experience of the cesarean section and post-operative pain management and anesthetic care
  • Pruritus [ Time Frame: 0-48 hours ]
    Is a positive to pruritus if the patients answers yes to the question, "have you experienced any itching" or if a drug was specifically used to treat itching via a review of the MAR
  • Nausea [ Time Frame: 0-48 hours ]
    Is a positive to nausea if the patients answers yes to the question, "have you experienced any nausea" or if a drug was specifically used to treat nausea via a review of the MAR
  • Vomiting [ Time Frame: 0-48 hours ]
    Is a positive to vomiting if the patients answers yes to the question, "have you experienced any vomiting" or if a drug was specifically used to treat vomiting via a review of the MAR
  • Chronic pain by pain scores [ Time Frame: 6 weeks post-partum ]
    Directly compare pain scores in the three groups at the six week visit, evaluating for chronic pain after Cesarean Section. Will use VAS score (0-10), pain at rest and pain with movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone
Official Title  ICMJE Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone, After Cesarean Section
Brief Summary More and more women are on buprenorphine or methadone during pregnancy for a history of opioid addiction. Currently, pain control after cesarean section for women already on these medications, if they need operative delivery, is a challenge due to the pharmacology of those drugs. They have higher pain scores and 45-47% higher opiates requirement. To improve pain control, some unique regional anesthesia techniques have been employed, besides opioid and non-opioid medication management through the oral, intravenous, and/or neuraxial (spinal or epidural) route. One is a TAP block ( transversus abdominis plane block), a regional anesthesia procedure in which long acting local anesthetic, such as ropivacaine, is injected on both sides of the patient's abdomen to numb the nerves supplying the abdominal wall, or the surgical site. Another is a patient - controlled epidural, a small flexible catheter that is inserted in the back into the epidural space near the spine, which bathes the spinal nerve roots with long acting local anesthetic, such as bupivacaine, and with an opioid, such as fentanyl, to numb the nerves going to the surgical site. Through an epidural pump, the patient receives a continuous infusion of local anesthetic and can delivery more medication as needed through a bolus feature. There have case reports, or case by case accounts, of these techniques, and it is suspected these techniques result in better pain control with minimal side effects. No clinical, human or animal, has evaluated these techniques in a controlled and through manner, either comparing the two techniques to each other or comparing them to the common care of opioid and non-opioid medication management through the oral, intravenous, and/or neuraxial route, including neuraxial hydromorphone or morphine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Caesarean Delivery
Intervention  ICMJE
  • Drug: TAP Block
    This intervention of a TAP block will be compared to the intervention of Common Care and to the intervention of Patient Controlled Epidural Analgesia
  • Drug: Ropivacaine
    The intervention of the Patient Controlled Epidural Analgesia will be compared to the intervention of a TAP block and the intervention of Common Care
  • Drug: Acetaminophen

    Common ways to treat pain control after Cesarean Section include oral and IV opioids, non-narcotic adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen, and long-acting spinal or epidural opioids such as morphine. Due to the potential issues such as ineffectiveness and fear of respiratory depression, increasing the dosing of these opioids may not be ideal.

    The intervention of Common Care will be compared to the intervention of a TAP block and the intervention of Patient Controlled Epidural Analgesia

  • Drug: Morphine
Study Arms  ICMJE
  • Active Comparator: TAP BLOCK
    One unique regional technique for lower abdominal surgery, that has been shown effective for Cesarean Section in particular, is the transversus abdominis plane (TAP) block, which blocks T6-L1 sensory nerve branches and provides anesthesia to the anterior abdominal wall. The TAP block has been recommended and shown in case reports, but not clinically studied with trials, for patients on methadone or buprenorphine, to improve post-operative pain control. A long active local anesthetic, called ropivacaine, will be used to provide this anesthesia.
    Interventions:
    • Drug: TAP Block
    • Drug: Acetaminophen
  • Active Comparator: Common Care
    Common care refers to the common way pain is treated after Cesarean Section: a long-acting spinal or epidural opioid such as morphine, plus oral and IV opioids and non-narcotic adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen. Due to the potential issues such as ineffectiveness and fear of respiratory depression, increasing the dosing of these opioids may not be ideal.
    Interventions:
    • Drug: Acetaminophen
    • Drug: Morphine
  • Active Comparator: Patient Controlled Epidural Analgesia
    For post-Cesarean analgesia, another regional technique that has been employed for superior pain control is continued epidural analgesia with local anesthesia and an opioid, either in addition or instead of long acting neuraxial opioids (Cohen). One study revealed equal analgesic efficiency, higher patient satisfaction scores, and less side effects with patient controlled epidural ropivacaine compared to epidural morphine (Chen). This is an especially attractive option for opioid dependent patients, but like the TAP block, has been not studied whether or not it lessens acute or chronic postoperative cesarean section, in the setting or in the absence of neuraxial opioids.
    Interventions:
    • Drug: Ropivacaine
    • Drug: Acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 4, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2014)
180
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anesthesiology Society of Anesthesiologist's Status of II or III
  • Maintenance methadone or buprenorphine during pregnancy
  • Regional anesthesia staff to perform a TAP block
  • Elective, non-urgent cesarean delivery via a Pfannenstiel incision under regional anesthesia

Exclusion Criteria:

  • Emergency cesarean section
  • Laboring patients who are now having to delivery operatively
  • Patients with a BMI over 50
  • Patients with allergies to any of the study medications
  • Patients under 18 years old
  • Patients with multiple gestations
  • Patients undergoing general anesthesia
  • Patients who had contraindications for either an epidural or a TAP block as in coagulopathies, chronic back pain, skin conditions, or existing neuropathies
  • Patients who cannot understand the use of a patient controlled epidural analgesia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02091297
Other Study ID Numbers  ICMJE D14074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
Investigators  ICMJE
Principal Investigator: Marnie B Welch, MD Dartmouth-Hitchcock Medical Center
Study Director: Michaela Farber, MD Brigham and Women's Hospital
Study Director: Lisa Leffert, MD Massachusetts General Hospital
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP